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FDA starts pilot after AstraZeneca, J&J make case for novel drug delivery excipients

September 14, 2021


Academic literature features a steady stream of papers on novel excipients with the potential to improve drug delivery but they rarely show up in newly approved drugs because companies shy away from the additional risk they entail. Recognizing that, the FDA has created a Novel Excipient Review Pilot Program to clear the logjam.

Multiple drug developers used the FDA’s call for comment on the proposed program late in 2019 to set out the drug delivery applications of novel excipients. Johnson & Johnson highlighted how the viscosity and protein instability of biologics at high concentrations restricts the ability of formulators to develop drugs in more convenient at-home subcutaneous injection formats.

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